Biological fluid collection device and biological fluid separation and testing system

ABSTRACT

A biological fluid collection device that is adapted to receive a blood sample having a cellular portion and a plasma portion is disclosed. After collecting the blood sample, the biological fluid collection device is able to transfer the blood sample to a point-of-care testing device or a biological fluid separation and testing device. After transferring the blood sample, the biological fluid separation and testing device is able to separate the plasma portion from the cellular portion and analyze the blood sample and obtain test results.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims priority to U.S. Provisional ApplicationNo. 61/811,918, filed Apr. 15, 2013, entitled “Medical Device forCollection of a Biological Sample”, the entire disclosure of which ishereby incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Disclosure

The present disclosure relates generally to devices, assemblies, andsystems adapted for use with vascular access devices. More particularly,the present disclosure relates to devices, assemblies, and systemsadapted for collecting biological samples for use in point-of-caretesting.

2. Description of the Related Art

Blood sampling is a common health care procedure involving thewithdrawal of at least a drop of blood from a patient. Blood samples arecommonly taken from hospitalized, homecare, and emergency room patientseither by finger stick, heel stick, or venipuncture. Blood samples mayalso be taken from patients by venous or arterial lines. Once collected,blood samples may be analyzed to obtain medically useful informationincluding chemical composition, hematology, or coagulation, for example.

Blood tests determine the physiological and biochemical states of thepatient, such as disease, mineral content, drug effectiveness, and organfunction. Blood tests may be performed in a clinical laboratory or atthe point-of-care near the patient. One example of point-of-care bloodtesting is the routine testing of a patient's blood glucose levels whichinvolves the extraction of blood via a finger stick and the mechanicalcollection of blood into a diagnostic cartridge. Thereafter, thediagnostic cartridge analyzes the blood sample and provides theclinician a reading of the patient's blood glucose level. Other devicesare available which analyze blood gas electrolyte levels, lithiumlevels, and ionized calcium levels. Some other point-of-care devicesidentify markers for acute coronary syndrome (ACS) and deep veinthrombosis/pulmonary embolism (DVT/PE).

Despite the rapid advancement in point-of-care testing and diagnostics,blood sampling techniques have remained relatively unchanged. Bloodsamples are frequently drawn using hypodermic needles or vacuum tubesattached to a proximal end of a needle or a catheter assembly. In someinstances, clinicians collect blood from a catheter assembly using aneedle and syringe that is inserted into the catheter to withdraw bloodfrom a patient through the inserted catheter. These procedures utilizeneedles and vacuum tubes as intermediate devices from which thecollected blood sample is typically withdrawn prior to testing. Theseprocesses are thus device intensive, utilizing multiple devices in theprocess of obtaining, preparing, and testing blood samples. Eachadditional device increases the time and cost of the testing process.

Point-of-care testing devices allow for a blood sample to be testedwithout needing to send the blood sample to a lab for analysis. Thus, itis desirable to create a device that provides an easy, safe,reproducible, and accurate process with a point-of-care testing system.

SUMMARY OF THE INVENTION

The present disclosure provides a biological fluid collection device,such as a blood collection device, that is adapted to receive a bloodsample having a cellular portion and a plasma portion. After collectingthe blood sample, the biological fluid collection device is able totransfer the blood sample to a point-of-care testing device or abiological fluid separation and testing device, such as a bloodseparation and testing device. After transferring the blood sample, thebiological fluid separation and testing device is able to separate theplasma portion from the cellular portion and analyze the blood sampleand obtain test results. In one embodiment, the biological fluidcollection device provides a closed system that reduces the exposure ofa blood sample to both skin and environment and provides fast mixing ofa blood sample with a sample stabilizer. The sample stabilizer can be ananticoagulant, or a substance designed to preserve a specific elementwithin the blood such as, for example, RNA, protein analyte, or otherelement.

In accordance with an embodiment of the present invention, a biologicalfluid collection device includes a lancet housing having an inlet portand an interior defining a first flow channel in fluid communicationwith the inlet port. The device also includes a second flow channel influid communication with the first flow channel, and at least a portionof the second flow channel is diverted from the first flow channel. Thedevice also includes a puncturing element which is moveable between apre-actuated position, in which the puncturing element is retainedwithin the interior, and a puncturing position, in which the puncturingelement extends through the inlet port of the housing and provides fluidcommunication with the first flow channel. The device also includes atransfer cartridge having a reservoir, and the second flow channel is influid communication with the reservoir of the transfer cartridge.

In certain configurations, the first flow channel is adapted to receivea blood sample therein. The first flow channel may be dimensioned toreceive the first blood provided to the flow channel. The first flowchannel may include a reservoir region spaced apart from the inlet port,and a truncated region spaced apart from the reservoir region. Thesecond flow channel may be provided in fluid communication with thetruncated region. The transfer cartridge may be removably engageablewith a portion of the housing. An internal fill volume of the reservoirmay correspond to a volume of fluid required to perform a diagnostictest. At least one of the first flow channel and the second flow channelmay include a vent to atmosphere.

In accordance with another embodiment of the present invention, abiological fluid separation device includes a rotatable body having acenter of rotation and an outer periphery. The rotatable body has a bodyinlet adapted to receive a multi-component blood sample. The device alsoincludes a separation chamber defined within the rotatable body and influid communication with the body inlet. The separation chamber has achamber outlet spaced apart from the body inlet, and the separationchamber is adapted to receive the multi-component blood sample. Thedevice also includes a blood component chamber defined within therotatable body and in fluid communication with the chamber outlet. Whena rotational force is applied to the rotatable body, a component of themulti-component blood sample passes from the separation chamber into theblood component chamber and a second component of the multi-componentblood sample is retained within the separation chamber. The bloodcomponent chamber is disposed adjacent the center of rotation and theseparation chamber is disposed adjacent the outer periphery of therotatable body.

In certain configurations, the blood component is a plasma component ofthe multi-component blood sample and the second component is a cellularcomponent of the multi-component blood sample. The device may alsoinclude a diagnostic chamber in fluid communication with the bloodcomponent chamber. The rotatable body may be disc-shaped. In otherconfigurations, the blood component chamber receives the blood componentof the multi-component blood sample upon the rotatable body beingrotated by a processing instrument. The device may also include adiagnostic chamber in fluid communication with the blood componentchamber and a detection zone readable by a processing instrument.

In accordance with another embodiment of the present invention, abiological fluid separation and testing system, such as a bloodseparation and testing system, for a multi-component blood sampleincludes a biological fluid collection device. The biological fluidcollection device includes a lancet housing having an inlet port and aninterior defining a first flow channel in fluid communication with theinlet port. The device also includes a second flow channel in fluidcommunication with the first flow channel, and at least a portion of thesecond flow channel is diverted from the first flow channel. The devicealso includes a puncturing element moveable between a pre-actuatedposition, wherein the puncturing element is retained within theinterior, and a puncturing position, wherein the puncturing elementextends through the inlet port of the housing and provides fluidcommunication with the first flow channel. The device further includes atransfer cartridge having a reservoir, with the second flow channel influid communication with the reservoir of the transfer cartridge. Thesystem also includes a biological fluid separation device, such as ablood separation device, including a rotatable body having a center ofrotation and an outer periphery. The rotatable body has a body inletadapted to receive the multi-component blood sample. The separationdevice also includes a separation chamber defined within the rotatablebody and in fluid communication with the body inlet. The separationchamber also has a chamber outlet spaced apart from the body inlet, withthe separation chamber adapted to receive the multi-component bloodsample therein. The separation device further includes a blood componentchamber defined within the rotatable body and in fluid communicationwith the chamber outlet. When a rotational force is applied to therotatable body, a component of the multi-component blood sample passesfrom the separation chamber into the blood component chamber and asecond component of the multi-component blood sample is retained withinthe separation chamber. The blood component chamber is disposed adjacentthe center of rotation and the separation chamber is disposed adjacentthe outer periphery of the rotatable body, and the body inlet isengagable with the reservoir of the transfer cartridge.

In certain configurations, a portion of the rotatable body is threadablyengageable with a portion of the transfer cartridge for aligning thebody inlet in fluid communication with the reservoir. The first flowchannel may be dimensioned to receive the first blood provided to theflow channel. The transfer cartridge may be removably engageable with aportion of the housing and subsequently engageable with a portion of therotatable body.

In other configurations, at least one of the first flow channel and thesecond flow channel includes a vent to atmosphere. The system may alsoinclude a diagnostic chamber in fluid communication with the bloodcomponent chamber. In certain configurations, the blood component is aplasma component of the multi-component blood sample and the secondcomponent is a cellular component of the multi-component blood sample.The blood component chamber may receive the component of themulti-component blood sample upon the rotatable body being rotated by aprocessing instrument. The system may also include a diagnostic chamberin fluid communication with the blood component and including adetection zone readable by a processing instrument.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of a biological fluid collection device inaccordance with an embodiment of the present invention.

FIG. 2 is an assembled, perspective view of a biological fluidcollection device in accordance with an embodiment of the presentinvention, with a transfer cartridge received within a portion of alancet housing.

FIG. 3 is a cross-sectional view of a portion of a biological fluidcollection device in accordance with an embodiment of the presentinvention.

FIG. 4 is a perspective view of a biological fluid collection device inaccordance with an embodiment of the present invention, with a lancethousing in a first position.

FIG. 5 is a cross-sectional view of a lancet housing in accordance withan embodiment of the present invention.

FIG. 6 is a perspective view of a biological fluid collection device inaccordance with an embodiment of the present invention, with a lancethousing in a second position.

FIG. 7 is a perspective view of a transfer cartridge and a biologicalfluid separation and testing device in accordance with an embodiment ofthe present invention.

FIG. 8 is an elevation view of a biological fluid separation and testingdevice in accordance with an embodiment of the present invention.

FIG. 9 is a perspective view of a processing and analyzing instrument inaccordance with an embodiment of the present invention.

FIG. 10 is a cross-sectional view of a valve of a transfer cartridge inaccordance with an embodiment of the present invention, with the valvein a closed position.

FIG. 11 is a cross-sectional view of a valve of a transfer cartridge inaccordance with an embodiment of the present invention, with the valvein an open position.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume alternative variations and step sequences,except where expressly specified to the contrary. It is also to beunderstood that the specific devices and processes illustrated in theattached drawings, and described in the following specification, aresimply exemplary embodiments of the invention. Hence, specificdimensions and other physical characteristics related to the embodimentsdisclosed herein are not to be considered as limiting.

Various point-of-care testing devices are known in the art. Suchpoint-of-care testing devices include test strips, glass slides,diagnostic cartridges, or other testing devices for testing andanalysis. Test strips, glass slides, and diagnostic cartridges arepoint-of-care testing devices that receive a blood sample and test thatblood for one or more physiological and biochemical states. There aremany point-of-care devices that use cartridge based architecture toanalyze very small amounts of blood bedside without the need to send thesample to a lab for analysis. This saves time in getting results overthe long run but creates a different set of challenges versus the highlyroutine lab environment. Examples of such testing cartridges include thei-STAT® testing cartridge from the Abbot group of companies. Testingcartridges such as the i-STAT® cartridges may be used to test for avariety of conditions including the presence of chemicals andelectrolytes, hematology, blood gas concentrations, coagulation, orcardiac markers. The results of tests using such cartridges are quicklyprovided to the clinician.

However, the samples provided to such point-of-care testing cartridgesare currently manually collected with an open system and transferred tothe point-of-care testing cartridge in a manual manner that often leadsto inconsistent results, thereby negating the advantage of thepoint-of-care testing device. Accordingly, a need exists for a systemfor collecting and transferring a sample to a point-of-care testingdevice that provides safer, reproducible, and more accurate results.Accordingly, a point-of-care collecting and transferring system of thepresent disclosure will be described hereinafter. A system of thepresent disclosure enhances the reliability of the point-of-care testingdevice by: 1) incorporating a more closed type of sampling and transfersystem; 2) minimizing open exposure of the sample; 3) improving samplequality; and 4) improving the overall ease of use.

FIGS. 1-9 illustrate an exemplary embodiment of the present disclosure.Referring to FIGS. 1-9, a biological fluid collection device, such as ablood collection device 10, of the present disclosure is adapted toreceive a multi-component blood sample 12 having a cellular portion 14and a plasma portion 16.

FIG. 7 illustrates an exemplary embodiment of the present disclosure.Referring to FIG. 7, a biological fluid separation and testing system,such as a blood separation and testing system 20, of the presentdisclosure includes a blood collection device 10 and a biological fluidseparation and testing device, such as a blood separation and testingdevice, or point-of-care testing device 22 engageable with the bloodcollection device 10 for closed transfer of a blood sample 12 from theblood collection device 10 to the blood separation and testing device22. After transferring the blood sample 12, the blood separation andtesting device 22 is able to separate the plasma portion 16 from thecellular portion 14 of the multi-component blood sample and analyze theblood sample and obtain test results.

Referring to FIGS. 1-6, the blood collection device 10 includes a lancethousing 26 and a transfer cartridge 28 that is removably engageable witha portion of the lancet housing 26. The lancet housing 26 generallyincludes a top portion 30, a bottom portion 31, a central aperture orinterior 32, an inlet port 34, a first flow channel 36, a second flowchannel 38, a reservoir region 40, a truncated region 42, a puncturingelement engagement portion 44, an adhesive 46 on the bottom portion 31of the lancet housing 26, and a transfer cartridge receiving cavity 48.The inlet port 34 and the first flow channel 36 are adapted to receive ablood sample therein.

In one embodiment, the lancet housing 26 includes a diverted and ventedchamber or reservoir region 40 that pulls off a first drop of blood. Inone embodiment, the reservoir region 40 includes a vent or a vent hole.In another embodiment, the reservoir region 40 could contain a smallsponge or a wicking material that assists in drawing a first drop ofblood. In yet another embodiment, the reservoir region 40 could includea passive valve design. For example, the reservoir region 40 couldinclude structure that would fill the reservoir region 40 first and onlyonce the reservoir region 40 is sufficiently filled would a barrier,such as a capillary break, be overcome thereby allowing a blood sampleto flow to the transfer cartridge 28. In other embodiments, the bloodcollection device 10 could include any mechanism that is adapted to pulla first drop of blood into the reservoir region 40 without the firstdrop of blood flowing to the transfer cartridge 28.

In one embodiment, the lancet housing 26 includes the first flow channel36 that is in fluid communication with the inlet port 34 and the secondflow channel 38 is in fluid communication with the first flow channel36. In one embodiment, at least a portion of the second flow channel 38is diverted from the first flow channel 36. In one embodiment, at leastone of the first flow channel 36 and the second flow channel 38 includesa vent to atmosphere.

Referring to FIG. 3, in one embodiment, the first flow channel 36 of thelancet housing 26 includes a reservoir region 40 that is spaced apartfrom the inlet port 34 and a truncated region 42 that is spaced apartfrom the reservoir region 40. In one embodiment, the second flow channel38 of the lancet housing 26 is provided in fluid communication with thetruncated region 42.

Referring to FIGS. 1-6, the blood collection device 10 also includes apuncturing element structure 70 that may be secured within the centralaperture or interior 32 of the lancet housing 26. The puncturing elementstructure 70 generally includes a first end 72, a second end 74, a pushbutton 76 adjacent the first end 72, a puncturing element 78 adjacentthe second end 74, and a housing engagement portion 80. The housingengagement portion 80 engages the puncturing element engagement portion44 of the lancet housing 26 for securing the puncturing elementstructure 70 to the lancet housing 26 within the central aperture 32 asshown in FIG. 5. The puncturing element structure 70 includes apuncturing element 78 having a puncturing end 82. The puncturing end 82is adapted for puncturing the skin surface S of a patient (FIG. 4), andmay define a pointed end, a blade edge, or a similar cutting mechanism.The puncturing end 82 may include a preferred alignment orientation,such as with a pointed end of a blade aligned in a specific orientation.In one embodiment, the puncturing element 78 comprises a micro-needlearray.

The puncturing element 78 is adapted for movement between a pre-actuatedposition wherein the puncturing element 78 including the puncturing end82 is retained within the interior 32 of the lancet housing 26 and apuncturing position wherein the puncturing end 82 of the puncturingelement 78 extends through the inlet port 34 of the lancet housing 26 topuncture a skin surface S of a patient to draw a blood sample 12. In oneembodiment, actuation of the push button 76 moves the puncturing element78 from the pre-actuated position to the puncturing position.

In one embodiment, the lancet housing 26 of the blood collection device10 may include a self-sealing dock that would allow an external lancetor puncturing element to be removably received within the lancet housing26. The external lancet or puncturing element could be eitherpre-integrated into the packaged blood collection device 10 orintroduced separately by a user before using the blood collection device10 of the present disclosure.

Referring to FIGS. 1-4, the bottom portion 31 of the lancet housing 26includes an adhesive or adhesive layer 46 so that the blood collectiondevice 10 can be secured onto a skin surface S of a patient where ablood sample will be accessed. In one embodiment, the adhesive 46 of thebottom portion 31 is protected by a peel-off layer, similar to anadhesive bandage, which would be removed before placing the bloodcollection device 10 on the skin surface S of the patient's body. Ahydrogel or other layer could be included to provide some thickness tothe bottom portion 31 and help improve the stability of the adhesiveseal. Additionally, in one embodiment, the adhesive 46 could include achemistry to create a more liquid-tight seal, similar to painter's tapetechnology, where wetting from the paint itself causes a chemicalreaction with the adhesive 46 to create a more water-tight barrier toprevent the paint from seeping under the tape. Importantly, the adhesiveprovides for proper adhesion of the lancet housing 26 to the skinsurface S of a patient and minimizes skin contact which leads to abetter sample for coagulation testing. The adhesive 46 of the lancethousing 26 can be punctured by the puncturing element 78 such that theblood evolving from the wound beneath passes through the cut into thelancet housing 26 to be collected inside the blood collection device 10.

Referring to FIGS. 1-11, the transfer cartridge 28 includes a first wallportion 50, a second wall portion 52, a transfer port 54, a reservoir68, and a valve or septum 86 at the transfer port 54. In one embodiment,an internal fill volume of the reservoir 68 of the transfer cartridge 28corresponds to a volume of fluid required to perform a diagnostic test.

The transfer port 54 of the transfer cartridge 28 may include a valve orseptum 86 that is transitionable between a closed position and an openposition. With the valve 86 in an open position, the blood sample 12 mayflow through the reservoir 68 of the transfer cartridge 28 to a bloodseparation and testing device 22 as described in more detail below.

Referring to FIG. 2, a portion of the transfer cartridge 28 can bereceived within the transfer cartridge receiving cavity 48 of the lancethousing 26. In this initial position, the second flow channel 38 of thelancet housing 26 is in fluid communication with the reservoir 68 of thetransfer cartridge 28 so that a collected blood sample 12 can flowthrough the inlet port 34 of the lancet housing 26 to the reservoir 68of the transfer cartridge 28. When the reservoir 68 of the transfercartridge 28 is filled with a blood sample 12, the clinician or patientcan remove the transfer cartridge 28 from the lancet housing 26 as shownin FIG. 1. When removed, the reservoir 68 of the transfer cartridge 28and all flow channels of the lancet housing 26 are sealed from theexternal environment.

In one embodiment, with the transfer cartridge 28 received within thetransfer cartridge receiving cavity 48 of the lancet housing 26, thefirst wall portion 50 is received within the transfer cartridgereceiving cavity 48 and the second wall portion 52 of the transfercartridge 28 extends outward from the transfer cartridge receivingcavity 48. In this manner, the second wall portion 52 of the transfercartridge 28 can be grasped by a user to remove the transfer cartridge28 from the lancet housing 26.

The blood collection device 10 may also include a layer of samplestabilizer. For example, in one embodiment, a blood sample 12 that iscollected within the blood collection device 10 may be exposed to andmixed with a sample stabilizer in a portion of the lancet housing 26 orthe transfer cartridge 28. The sample stabilizer can be ananticoagulant, or a substance designed to preserve a specific elementwithin the blood such as, for example, RNA, protein analyte, or otherelement. In one embodiment, the sample stabilizer may be disposed in aportion of the lancet housing 26. In another embodiment, the samplestabilizer may be disposed in a portion of the transfer cartridge 28 orany other area of the blood collection device 10 in which it contacts ablood sample.

Referring to FIGS. 7 and 8, a blood separation and testing device orpoint-of-care testing device 22 includes a rotatable body 100 having acenter of rotation 102 and an outer periphery 104, a body inlet orreceiving port 106, a separation chamber 108, a flow channel 110, ablood component chamber, such as a plasma chamber 112, and a diagnosticportion or diagnostic chamber 114 in fluid communication with the plasmachamber 112. In one embodiment, the diagnostic chamber includes adetection zone 116 that is readable by a processing and analyzinginstrument 200 (FIG. 9). In one embodiment, the rotatable body 100 isdisc-shaped.

The receiving port or body inlet 106 is adapted to receive the valve 86of the transfer port 54 of the transfer cartridge 28. The bloodseparation and testing device 22 is adapted to receive the valve 86 ofthe transfer port 54 of the transfer cartridge 28 for closed transfer ofa portion of the blood sample 12 from the reservoir 68 of the transfercartridge 28 to the blood separation and testing device 22. The bloodseparation and testing device 22 is able to separate the plasma portion16 from the cellular portion 14 and analyze the blood sample 12 andobtain test results.

The separation chamber 108 is defined within the rotatable body 100 andis in fluid communication with the body inlet 106 and the separationchamber 108 includes a chamber outlet or flow channel 110 spaced apartfrom the body inlet 106. The separation chamber 108 is adapted toreceive both the cellular portion 14 and the plasma portion 16 therein.

The blood component chamber, such as the plasma chamber 112, is definedwithin the rotatable body 100 and is in fluid communication with theseparation chamber 108 via the flow channel or chamber outlet 110. Whena rotational force is applied to the rotatable body 100, the plasmaportion 16 passes from the separation chamber 108 into the plasmachamber 112 and the cellular portion 14 is retained within theseparation chamber 108. In one embodiment, the plasma chamber 112receives the plasma portion 16 of the blood sample 12 upon the rotatablebody 100 being rotated by a processing and analyzing instrument 200. Inone embodiment, the plasma chamber 112 is disposed adjacent the centerof rotation 102 and the separation chamber 108 is disposed adjacent theouter periphery 104 of the rotatable body 100.

Once a blood sample 12 is received into the blood separation and testingdevice 22, the blood separation and testing device 22 may be insertedinto a processing and analyzing instrument 200 that processes andanalyzes the blood sample 12. First, the blood separation and testingdevice 22 is spun at a high rate and the plasma portion 16 is separatedfrom the cellular portion 14 in the separation chamber 108. Then, thespeed is slowed down to drive the plasma portion 16 to the plasmachamber 112 in a central portion of the blood separation and testingdevice 22. The plasma portion 16 can then be processed inline throughthe diagnostic portion 114 of the blood separation and testing device22. Since the blood separation and testing device 22 may be of a compactdisc format, the detection zone 116 is read by the internal laser of theprocessing and analyzing instrument 200 while it is still spinning orrunning.

Referring to FIG. 7, a blood separation and testing device 22 includes areceiving port or body inlet 106 adapted to receive the transfer port 54of the transfer cartridge 28. The blood separation and testing device 22is adapted to receive the transfer port 54 of the transfer cartridge 28for closed transfer of a portion of the blood sample 12 from thereservoir 68 of the transfer cartridge 28 to the blood separation andtesting device 22. The blood separation and testing device 22 is able toseparate the plasma portion 16 from the cellular portion 14 and analyzethe blood sample 12 and obtain test results.

As discussed above, the transfer port 54 of the transfer cartridge 28may include a valve or septum 86 that is transitionable between a closedposition and an open position. With the valve or septum 86 in an openposition (FIG. 11), the blood sample 12 may flow through the transferport 54 to the body inlet 106 of the blood separation and testing device22.

In one embodiment, referring to FIGS. 10 and 11, the valve 86 maygenerally include a transfer channel 90, a bellows or deformable wallmember 92, and a septum or barrier 94 having a first barrier wall 96 anda second barrier wall 98. Referring to FIG. 10, the valve 86 is in aclosed position to prevent the blood sample 12 from flowing through thetransfer port 54. In this manner, the blood sample 12 is sealed withinthe transfer cartridge 28. Referring to FIG. 11, the valve 86 is in anopen position so that the blood sample 12 may flow through the transferport 54 to a blood separation and testing device 22.

Referring to FIG. 11, with the blood sample 12 received within thetransfer port 54 of the transfer cartridge 28, the transfer port 54 ofthe transfer cartridge 28 is then positioned over the receiving port orbody inlet 106 of the blood separation and testing device 22. Pushingdown in the direction of arrow B compresses the deformable wall member92 and opens up the first barrier wall 96 and the second barrier wall 98of the septum 94 as shown in FIG. 11. With the valve 86 in the openposition, the blood sample 12 is allowed to flow through the transferport 54 and to the blood separation and testing device 22 in a closedmanner reducing exposure to the clinician and the patient.

The valve 86 of the transfer cartridge 28 only opens when the transferport 54 is pressed upon the receiving port 106 of the blood separationand testing device 22. This releases the blood sample 12 directly intothe receiving port 106 of the blood separation and testing device 22,thus mitigating unnecessary exposure to the patient's blood.

In one embodiment, a portion of the rotatable body 100 of the bloodseparation and testing device 22 is threadably engageable with a portionof the transfer cartridge 28 for aligning the body inlet 106 in fluidcommunication with the reservoir 68 of the transfer cartridge 28.

Referring to FIGS. 1-11, use of a blood collection device of the presentdisclosure will now be described. Referring to FIG. 4, upon selecting asite, a clinician can adhere the adhesive 46 on the bottom portion 31 ofthe lancet housing 26 onto a skin surface S of a patient where a bloodsample will be accessed over a selected sampling site.

Next, the push button 76 on the blood collection device 10 is depressedor actuated to move the puncturing element 78 from the pre-actuatedposition to the puncturing position so that the puncturing element 78punctures the skin surface S of a patient. Thereafter, referring to FIG.6, the blood collection device 10 is rolled back to collect a bloodsample 12 into the reservoir 68 of the transfer cartridge 28 via theinlet port 34 of the lancet housing 26. In one embodiment, the bloodsample 12 is exposed to and mixed with a sample stabilizer in a portionof the lancet housing 26 or the transfer cartridge 28. The samplestabilizer can be an anticoagulant, or a substance designed to preservea specific element within the blood such as, for example, RNA, proteinanalyte, or other element.

When the reservoir 68 of the transfer cartridge 28 is filled, theclinician or patient can remove the transfer cartridge 28 from thelancet housing 26 as shown in FIG. 1. When removed, the reservoir 68 ofthe transfer cartridge 28 and all flow channels of the lancet housing 26are sealed from the external environment.

Referring to FIG. 7, the next step of the process involves insertion ofthe transfer cartridge 28 into a blood separation and testing device 22to transfer a blood sample from the transfer cartridge 28 to the bloodseparation and testing device 22. In one embodiment, the bloodseparation and testing device 22 may be a compact disc separation andtesting system that is utilized as a point-of-care testing device.

Referring to FIGS. 7 and 11, the transfer port 54 of the transfercartridge 28 is positioned over the receiving port or body inlet 106 ofthe blood separation and testing device 22. Pushing down in thedirection of arrow B compresses the deformable wall member 92 and opensup the first barrier wall 96 and the second barrier wall 98 of theseptum 94 as shown in FIG. 11. With the valve 86 in the open position,the blood sample 12 is allowed to flow through the transfer port 54 andto the blood separation and testing device 22 in a closed mannerreducing exposure to the clinician and the patient. The valve 86 of thetransfer cartridge 28 only opens when the transfer port 54 is pressedupon the receiving port 106 of the blood separation and testing device22. This releases the blood sample 12 directly into the receiving port106 of the blood separation and testing device 22, thus mitigatingunnecessary exposure to the patient's blood.

Once a blood sample 12 is received into the blood separation and testingdevice 22, the blood separation and testing device 22 may be insertedinto a processing and analyzing instrument 200 that processes andanalyzes the blood sample 12. First, the blood separation and testingdevice 22 is spun at a high rate and the plasma portion 16 is separatedfrom the cellular portion 14 in the separation chamber 108. Then, thespeed is slowed down to drive the plasma portion 16 to the plasmachamber 112 in a central portion of the blood separation and testingdevice 22. The plasma portion 16 can then be processed inline throughthe diagnostic portion 114 of the blood separation and testing device22. Since the blood separation and testing device 22 may be of a compactdisc format, the detection zone 116 is read by the internal laser of theprocessing and analyzing instrument 200 while it is still spinning orrunning.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. A biological fluid separation and testing systemfor a multi-component blood sample, comprising: a biological fluidcollection device, comprising: a lancet housing having an inlet port andan interior defining a first flow channel in fluid communication withthe inlet port and a second flow channel in fluid communication with thefirst flow channel, wherein at least a portion of the second flowchannel is diverted from the first flow channel; a puncturing elementmoveable between a pre-actuated position wherein the puncturing elementis retained within the interior of the housing and a puncturing positionwherein the puncturing element extends through the inlet port of thehousing and provides fluid communication with the first flow channel;and a transfer cartridge having a reservoir, wherein the second flowchannel is in fluid communication with the reservoir of the transfercartridge; and a biological fluid separation device, comprising: arotatable body having a center of rotation and an outer periphery, therotatable body having a body inlet adapted to receive themulti-component blood sample; a separation chamber defined within therotatable body and in fluid communication with the body inlet and havinga chamber outlet spaced apart from the body inlet, the separationchamber adapted to receive the multi-component blood sample therein; anda blood component chamber defined within the rotatable body and in fluidcommunication with the chamber outlet, wherein when the separationchamber contains the multi-component blood sample and a rotational forceis applied to the rotatable body, a blood component of themulti-component blood sample passes from the separation chamber into theblood component chamber and a second component of the multi-componentblood sample is retained within the separation chamber, wherein theblood component chamber is disposed adjacent the center of rotation andthe separation chamber is disposed adjacent the outer periphery of therotatable body, and wherein the body inlet is engagable with thereservoir of the transfer cartridge for transferring the multi-componentblood sample from the reservoir of the transfer cartridge to thebiological fluid separation device.
 2. The biological fluid separationand testing system of claim 1, wherein a portion of the rotatable bodyis threadably engageable with a portion of the transfer cartridge foraligning the body inlet in fluid communication with the reservoir. 3.The biological fluid separation and testing system of claim 1, whereinthe first flow channel is dimensioned to receive the first bloodprovided to the flow channel.
 4. The biological fluid separation andtesting system of claim 1, wherein the transfer cartridge is removablyengageable with a portion of the housing and subsequently engageablewith a portion of the rotatable body.
 5. The biological fluid separationand testing system of claim 1, wherein at least one of the first flowchannel and the second flow channel includes a vent to atmosphere. 6.The biological fluid separation and testing system of claim 1, furthercomprising a diagnostic chamber in fluid communication with the bloodcomponent chamber.
 7. The biological fluid separation and testing systemof claim 1, wherein the blood component is a plasma component of themulti-component blood sample and the second component is a cellularcomponent of the multi-component blood sample.
 8. The biological fluidseparation and testing system of claim 1, wherein the blood componentchamber receives the blood component of the multi-component blood sampleupon the rotatable body being rotated by a processing instrument.
 9. Thebiological fluid separation and testing system of claim 1, furthercomprising a diagnostic chamber in fluid communication with the bloodcomponent and including a detection zone readable by a processinginstrument.